Effect of Transcutaneous Electrical Stimulation on Post-stroke Dysphagic Patients

Dysphagia Clinical Trial

— EETI-01  

Official title:

Pilot Study to Evaluate the Efficacy and Safety of Transcutaneous Electrical Stimulation on Swallowing in Patients With Oropharyngeal Dysphagia After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363973
• Other study ID #: EETI-01
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: February 27, 2015
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2015
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Oropharyngeal dysphagia (OD, swallowing dysfunction) is a major complaint following stroke. Despite its enormous impact on functional capacity, quality of life, and survival, OD is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. A recent systematic review on the effects of rehabilitation therapy on OD concluded that although some positive effects were found, the number of studies was small, many of them had methodological problems and there was a need for further research using randomized controlled trials. Transcutaneous electrical stimulation was approved by the FDA as a treatment of dysphagia in June 2001 and is traditionally used to activate pharyngeal muscles through stimulation of peripheral motor nerves (neuromuscular electrical estimulation, NMES). However, their real effectiveness and safety in the treatment of dysphagia is still matter of discussion (Logemann Dysphagia 2007, Ludlow dysphagia 2007) and studies evaluating NMES therapy, present discordant results. On the other hand, in recent years, transcutaneous electrical stimulation is beginning to use as a sensory strategy (Gallas 2010), avoiding muscle contraction during the treatment.Our research strategy includes the assessment of the therapeutic effect of these two main strategies using transcutaneous electrical stimulation on swallow physiology and clinical outcomes of post-stroke dysphagic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Background of swallowing difficulties associated with stroke, more than 3 months of evolution

• Study explained and signed informed consent

Exclusion Criteria:

• Patients who are suspected or can not meet the protocol. patients who are participating or have participated in a trial last 4 weeks. Patients with active cancer Patients with active infectious process. patients with severe dementia or inability to communicate. patients with neurodegenerative diseases. patients with pacemakers. patients with implanted electrodes. patients with epilepsy or seizure disorders. patients with gastroesophageal reflux.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Device:
• VITALSTIM transcutaneous electrical stimulation

Locations

Country	Name	City	State
Spain	Hospital de Mataró	Mataró	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Mataró	Centro de Investigación Biomédica en Red

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of swallow	Prevalence of penetrations or aspirations after the treatment	5 days	No
Secondary	Efficacy of swallow	Prevalence of residue after the treatment	5 days	No